NCT03290599

Brief Summary

Post-operative cognitive dysfunction is defined as a decrease in cognitive functions which develop following surgery and anesthesia administration that can last up to weeks or even months after surgery. In this study, our main objective was to investigate the effect of preoperative hospitalisation period on early post operative cognitive dysfunction development and its risk factors in patients who underwent total hip replacement surgery for hip fractures under regional anesthesia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

September 17, 2017

Last Update Submit

September 20, 2017

Conditions

Keywords

Cognitive dysfunctionHip SurgeryMini mental Test,Preoperative HospitalisationSpinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Post operative Cognitive Dysfunction

    Mini mental test

    change of Mini mental test score from hospitalisation time to post operative 24th hour

Study Arms (2)

No Post operative cognitive dysfunction

Patients who did not have any change or a change less than 4 points between MMT1 and MMT3

Other: Mini Mental and Modified Mini Mental Test

Post operative cognitive dysfunction

Patients with a difference more than 4 points between MMT1 and MMT3

Other: Mini Mental and Modified Mini Mental Test

Interventions

Mini Mental Test was used for literate patients and Modified mini mental test was used for illiterated patients

No Post operative cognitive dysfunctionPost operative cognitive dysfunction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent total hip replacement surgery over 18 aged

You may qualify if:

  • Patients who were planned to undergo total hip replacement surgery without cement over 18 years of age and within ASA Group 1, 2 and 3 according to ASA physical status score were included in the study.

You may not qualify if:

  • Patients younger than 18, who did not speak Turkish, with known cancer history, previous steroid treatment, SVO history in last 6 months, with central nervous system diseases (current meningitis, encephalitis, tumors, major degenerative diseases), with dementia, Alzheimer's and Parkinson's Disease, pregnant patients, patients with neuropsychiatric diseases or received antidepressant, antipsychotic or anticonvulsive treatment in the last 6 months, uncooperative patients, patients with substance abuse problems, patients with severe organ failure (end-stage liver failure, dialysis-dependent kidney failure), patients who required ICU following surgery, patients where regional anesthesia was contraindicated (Idiopathic intracranial hypertension (IIH), clotting disorders, infection on operational site) were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Burcu OZALP HORSANALI

Study Record Dates

First Submitted

September 17, 2017

First Posted

September 25, 2017

Study Start

November 1, 2013

Primary Completion

September 30, 2014

Study Completion

September 30, 2014

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share